1.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
Jiaqi LAI ; Qian HUANG ; Xueyin CHEN ; Shaonan LIU ; Lihong YANG ; MIMAZHUOGA ; DAWA ; Zhijian LI ; Tuerxun WUFUER ; Xinfeng GUO
Journal of Traditional Chinese Medicine 2026;67(13):1461-1464
Current formulation of objective performance criteria (OPC) in traditional Chinese medicine (TCM) faces methodological challenges, including poor reporting quality, insufficient standardization of methods, limited comparability of study populations, and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues, this paper proposes optimization strategies for setting OPC in TCM, with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions, ensuring transparency in meta-analyses and data sources; standardizing the estimation of point estimates and confidence intervals, and incorporating multidisciplinary expert consensus for value determination; introducing local real-world data from the same period, especially cohort study evidence, to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms, the credibility of OPC method can be enhanced, thereby providing methodological support for strengthening evidence-based research capacity in this field.
2.Efficacy and safety of pegylated interferon α-2b in treatment of patients with hepatitis B virus-related compensated liver cirrhosis: A real-world study
Yan WANG ; Lihong LI ; Anna WANG ; Jing WEN ; Jie YANG ; Yinong FENG ; Ye ZHANG ; Qianhui WANG
Journal of Clinical Hepatology 2026;42(7):1597-1606
ObjectiveTo investigate the antiviral efficacy of pegylated interferon α-2b (PEG-IFN-α-2b) in patients with HBV-related liver cirrhosis, to assess the safety and tolerability of this regimen, and to provide evidence-based medical evidence for optimizing the treatment strategies for patients with HBV-related compensated liver cirrhosis. MethodsA prospective study was conducted among 115 patients with HBV-related compensated liver cirrhosis and 114 patients with CHB who attended Third People’s Hospital of Taiyuan from January 2023 to March 2024. Treatment-naïve patients received PEG-IFN-α-2b monotherapy, while the patients once treated with nucleos(t)ide analogues (NAs) received PEG-IFN-α-2b add-on therapy. The patients with HBV-related compensated liver cirrhosis were followed up at baseline and at 12, 24, 36, and 48 weeks of treatment. Samples were collected from CHB patients at baseline and at the end of follow-up to assess virological indicators, routine blood test results, and liver function. The chi-square test was used for comparison of categorical data between groups; the independent samples t-test was used for comparison of normally distributed continuous data between two groups, and the one-way repeated measures analysis of variance was used for comparison among different time ponts within the same group,and the Bonferroni was applied for post-hoc pairwise comparisons; the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the Friedman test was used for comparison across different time points within the same group, and the Nemenyi test was utilized for subsequent pairwise comparisons. The multivariate stepwise Logistic regression analysis was used to investigate the influencing factors for clinical cure. ResultsCompared with the CHB group, the HBV-related compensated liver cirrhosis group had a significantly higher mean age (43.50±9.97 years vs 40.90±8.16 years, t=2.160, P=0.032), a significantly higher proportion of patients with hepatitis B e antigen at baseline (28.70% vs 15.79%, χ2=4.788, P=0.029), and a significantly lower platelet level [(178.67±55.07)×109/L vs (194.93±55.79)×109/L, t=2.217, P=0.028]. Compared with the CHB group at the end of follow-up, the HBV-related compensated liver cirrhosis group had significantly lower HBV surface antigen (HBsAg) clearance rate (10.38% vs 33.04%, χ2=14.988, P<0.001) and HBV surface antibody positive rate (0.00% vs 19.64%, χ2=21.041, P<0.001). Compared with the CHB group at the end of follow-up,the HBV-related compensated liver cirrhosis group had significantly lower aminotransferase levels [ALT: 31.00(19.00~47.50) U/L vs 40.00(27.00~57.00) U/L, Z=2.433, P<0.05; AST: 31.00(23.00~45.50) U/L vs 37.00(25.00~52.00) U/L, Z=1.963, P<0.05], but significantly higher level of white blood cells (WBC) [(4.02±1.56)×109/L vs (3.59±1.24)×109/L, t=2.272, P<0.05], neutrophils [(2.39±1.17)×109/L vs (1.87±0.94)×109/L, t=3.284, P<0.05], and platelets [(143.93±68.10)×109/L vs (121.88±49.72)×109/L, t=2.588, P<0.05]. A lower level of HBsAg (OR=0.997, 95%CI: 0.996 — 0.999, P<0.001) and previous treatment with NAs (OR=5.889, 95%CI: 2.195 — 17.330, P<0.001) were positive predictive factors for clinical cure, while liver cirrhosis (OR=0.177, 95%CI: 0.063 — 0.470, P<0.001) was a negative predictive factor for clinical cure. During follow-up, no patients experienced acute decompensation or progression to hepatocellular carcinoma, and the main adverse events included fever, fatigue, reductions in WBC and platelets, weight loss, alopecia, and thyroid dysfunction. In the subgroup analysis of HBV-related compensated liver cirrhosis, in both the treatment-naïve patients and the patients previously treated with NAs, there was a significant reduction in HBsAg level from baseline to week 36 of treatment [treatment-naïve: 99.25 (5.87 — 1 212.35) IU/mL vs 403.47 (36.94 — 2 569.02) IU/mL, P<0.05; previously treated with NAs: 205.94 (14.00 — 737.80) IU/mL vs 427.03 (65.64 — 1 552.65) IU/mL, P<0.05] and week 48 of treatment [treatment-naïve: 85.45 (0.58 — 827.56) IU/mL vs 403.47 (36.94 — 2 569.02) IU/mL, P<0.05; previously treated with NAs: 45.28 (0.16 — 267.27) IU/mL vs 427.03 (65.64 — 1 552.65) IU/mL, P<0.05]. There were significant increases in the levels of aminotransferases during treatment, as well as significant reductions in the levels of WBC, neutrophils, platelets, and hemoglobin (all P<0.05). ConclusionAlthough a finite course of PEG-IFN-α-2b therapy has achieved a relatively low rate of clinical cure in the treatment of HBV-related compensated liver cirrhosis, it can still significantly reduce the level of HBsAg, and this treatment regimen has good safety and tolerability, without accelerating disease progression.
3.Analysis of serum allergen specific IgE detection results in children with allergic diseases in Hangzhou area
Fenfang ZHU ; Jing CHEN ; Hongji JIA ; Haisong XU ; Ting JIANG ; Lihong YANG
Chinese Journal of Preventive Medicine 2025;59(9):1422-1426
To investigate the distribution and development of common allergens in children in Hangzhou area, and to provide an epidemiological basis for the prevention, diagnosis, and treatment of allergic diseases in this area. This study is a retrospective study, selecting 3 524 children who underwent allergen screening at DiAn Medical Laboratory Center (Hangzhou) Co., Ltd. from January 2022 to January 2024 as the research subjects, including 2 012 males and 1 512 females. Among them, there were 1 098 infants (0-1 year olds), 1 673 toddlers (1-3 year olds), and 753 children (3-14 year olds). Immunoblotting was used to detect 21 allergen-specific immunoglobulin E (sIgE) antibodies. The positive rates of various allergens were calculated according to gender, age, and other factors, and the epidemiological characteristics and trends were analyzed. The results showed that the overall positive rate of sIgE was 60.33% (2 126/3 524). The main inhaled allergens were Dermatophagoides pteronyssinus/Dermatophagoides farinae (992, 28.15%), dog dander (295, 8.37%) and cat dander (181, 5.13%). The main food allergens were milk (696, 19.75%), egg white (541, 15.36%) and shrimp (205, 5.83%). Boys had significantly higher sIgE positivity rates than girls for Dermatophagoides pteronyssinus/Dermatophagoides farinae(642, 31.90%, χ2=10.10, P=0.001), house dust(61, 3.02%, χ2=5.12, P=0.024), cat dander(124, 6.16%, χ2=4.06, P=0.044), mold combinations(103, 5.14%, χ2=7.51, P=0.006), and tree pollen combinations(42, 2.07%, χ2=5.44, P=0.020) (all P<0.05); With age, there was a significant increase in positivity rates for house dust mite/dust mite, house dust, mold combinations, milk, and beef (all P<0.05), and a significant decrease in positivity rates for cockroach consumption, egg whites, shrimp, crab, cod, lobster/scallop, and soybeans (all P<0.05), the positive rates of only ingestive allergens decreased significantly ( P<0.001), and the positive rates of only inhalant and mixed allergens increased significantly ( P<0.001). In conclusion,in the Hangzhou area, dust mites are the most common inhalant allergens among children with allergic diseases, while milk is the most common food allergen. Boys are more sensitive to inhalant allergens, and as children grow older, the positive rates for different allergens undergo significant changes. Dynamic monitoring of changes in specific IgE antibodies to various allergens can assist in the diagnosis, prevention, and treatment of allergic diseases.
4.Epidemiological characteristics analysis of monkey injury cases caused in Qianlingshan Park, Guiyang City, Guizhou Province
Cai YANG ; Yun CHEN ; Yu CHANG ; Li LI ; Qiying PAN ; Tingting LU ; Dan CHEN ; Chengxian HE ; Mei HUANG ; Liusong YANG ; Tingqin RAO ; Su GUO ; Chong LUO ; Lihong ZHOU ; Xin MU ; Li LIU ; Yayu YANG ; Yuandong HU
Chinese Journal of Preventive Medicine 2025;59(10):1685-1690
Objective:To analyze the epidemiological characteristics of cases involving monkey injuries at medical institutions surrounding Qianlingshan Park in Guiyang City, and to provide a reference basis for preventive measures to reduce monkey injuries and standardized post-exposure treatment.Methods:A retrospective cross-sectional study was conducted, collecting 1 900 cases of monkey-induced injuries in Qianlingshan Park treated at the outpatient clinic of Guizhou Provincial Center for Disease Control and Prevention and the Department of Surgery at Qianling Hospital, Guiyang City, from 2021 to 2024. Statistical analysis was performed using Pearson′s chi-square test.Results:Total of 1 900 cases of monkey-related injuries in Qianlingshan Park were collected from 2021 to 2024. The exposure time distribution exhibited significant seasonality, with 48.58% of cases occurring during July and August, totaling 923 cases, indicating a peak in the summer. There were 774 male patients and 1 126 female patients, with a ratio of 1∶1.45.and significant differences were observed between different age groups and genders (χ2=195.00, P<0.001), with the highest number of cases occurring in the 0-9 and 20-29 age groups, accounting for 22.05%(419 cases) and 21.79%(414 cases), respectively. The upper limbs were the most common injury site, accounting for 50.84% of the total cases(966 cases in total), with significant differences between gender and injury location (χ2=22.00, P<0.001), Among females, the proportion of injuries to the upper and lower limbs (30.11% and 16.47%, respectively) was higher than that among males (20.74% and 8.63%, respectively). The majority of injuries were classified as Grade Ⅲ, making up 57.38% of cases(1 069 cases in total). Self-treatment after exposure was the most common approach(60.44%), with significant differences observed between wound severity and treatment method (χ2=6.90, P=0.032), Patients with Grade Ⅱ and Grade Ⅲ wounds were more likely to choose self-management (26.84% and 33.23%, respectively) than outpatient management (15.14% and 24.15%). Approximately 98.05% (1 863 cases) of monkey-injured patients had received rabies vaccinations. Conclusions:This study analyzes monkey-related injuries in Qianlingshan Park from 2021 to 2024, clarifying the temporal distribution of injuries, demographic characteristics, injury sites, and treatment methods. The findings provide references for optimizing human-monkey conflict management and the prevention and control of zoonotic diseases in urban ecological parks.
5.Evaluation of the effect of benserazide combined with respiratory training on post-stroke dysphagia
Liya YANG ; Li ZHENG ; Lihong LI ; Yayong LI ; Jiang MA
Tianjin Medical Journal 2025;53(3):257-261
Objective To investigate the effect of benserazide combined with respiratory training on post-stroke dysphagia.Methods A total of 120 patients with dysphagia after stroke were prospectively selected and randomly divided into the combination group and the breathing exercise group,with 60 cases in each group.The breathing exercise group was treated with rehabilitation breathing training,and the combination group was treated with dopa serazide on the basis of rehabilitation breathing training,3 times a day,1 tablet once.The traditional Chinese medicine(TCM)syndrome scores,clinical efficacy and swallowing function indexes including dysphagia angiography score(VDS),osmotic-aspiration scale(PAS)score,Lowada drinking water test score and VFSS score were compared between the two groups.Nutritional indices[total cholesterol(TC),triglyceride(TG),albumin(ALB),hemoglobin(Hb)],related indexes of nerve function[nerve function and serum growth differentiation factor 15(GDF-15),central nerve specific protein soluble protein-100β(S100β)],quality of life and anxiety disorder score[Quality of Life Rating Scale(SF-36)score,Generalized Anxiety Disorder Scale(GAD-7)score]and adverse reactions were compared between the two groups.Results The total effective rate of the combination group(91.67%)was obviously increased(P<0.05)compared to the breathing exercise group(58.33%).Compared with before treatment,after treatment,tongue flaccidity,slow swallowing,choke after drinking water,tongue coating ecchymosis,score of fine pulse,VDS,PAS,score of Lowada drinking water test,GDF-15 level and GAD-7 score were decreased in the two groups,and those of the combination group were significantly lower than the breathing exercise group(P<0.05).The levels of TC,TG,ALB,Hb,S100β,VFSS and SF-36 were increased in the two groups,and those of the combination group were higher than the breathing exercise group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups.Conclusion Benserazide combined with respiratory training has high clinical efficacy in patients with post-stroke dysphagia,which can effectively improve the TCM evidence score and nutritional indicators,improve swallowing function,reduce anxiety,improve quality of life,and have more ideal clinical application.
6.An analysis of correlation between dyadic coping in patients with hematological tumors and their spouses and fear of progression
Xuehua LIU ; Jianhong WANG ; Lihong YANG ; Jiali LIU ; Yanping QIAO ; Xiaoyan LI
Chinese Journal of Nursing 2025;60(6):717-722
Objective To explore the impact of dyadic coping on fear of progression in patients with hematological tumors and their spouses based on the Actor-Partner Interdependence Model(APIM),and to provide references for clinical intervention.Methods By the convenient sampling method,136 pairs of hematological tumor patients and their spouses were selected from October 2023 to January 2024 in 5 tertiary hospitals in Shandong Province.A general information questionnaire,Dyadic Coping Inventory,Fear of Progression Questionnaire Short Form,and Fear of Progression Questionnaire Short Form/Partner Version were used to conduct the investigation.Amos 24.0 software was used to establish the APIM for dyadic coping with fear of progression.Results A total of 280 survey questionnaires were distributed,and 272 valid questionnaires were collected,including 136 from patients and their spouses,with an effective rate of 97.14%.The dyadic coping scores of hematological tumors patients and their spouses were(129.50±20.58)and(132.71±15.70),respectively,while the fear of progression scores were(31.71±3.13)and(29.01±3.05),respectively.Regarding the actors'effects,the level of dyadic coping strategies of patients and their spouses can both predict their own fear of progression,and are negatively correlated(β1=-0.52,β2=-0.41;P<0.001).Regarding the partners'effects,the degree of fear of progression in patients is negatively correlated with the dyadic coping level of their spouses(β=-0.19,P<0.001).Conclusion There is an interactive effect between the fear of progression and the level of dyadic coping between hematological tumor patients and their spouses.This suggests that clinical nursing staff should pay attention to the evaluation of fear of progression in patients with hematological tumors and their spouses,and effectively reduce the level of fear of progression on both sides.
7.Efficacy and safety of dupilumab in the treatment of atopic dermatitis in the elderly
Zijing YANG ; Lihong CHEN ; Yeping RUAN ; Wanting WEN ; Jiayi ZHANG ; Hailun WANG ; Meng PAN ; Xiaoqing ZHAO
Chinese Journal of Dermatology 2025;58(1):65-69
Objective:To investigate the efficacy and safety of dupilumab in the treatment of elderly patients (≥ 60 years old) with atopic dermatitis (AD), with particular attention paid to rare adverse reactions.Methods:A single-center retrospective analysis was conducted on data collected from 281 elderly AD patients who received the standard regimen of dupilumab at the Department of Dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine from January 2020 to May 2024. Clinical characteristics such as gender, disease duration, skin lesion manifestations, and itch severity were analyzed. Changes in skin lesions and itch severity, as well as related adverse events were recorded during the follow-up period of 0 - 16 weeks. The efficacy and safety of dupilumab in the treatment of elderly AD patients were evaluated.Results:Among the 281 elderly AD patients, 214 were males (76.16%) and 67 were females (23.84%), with the age being 71.13 ± 7.91 years and the age at onset being 59.92 ± 15.72 years. The disease duration ( M[ IQR]) was 5.00 (13.00) years. After standard-regimen dupilumab treatment, the improvement rates of clinical outcome indicators SCORing Atopic Dermatitis (SCORAD) and pruritus numerical rating scale (NRS) scores gradually increased. At week 16, the improvement rates of SCORAD and NRS scores ( M[ IQR]) reached the maxima of 72.37% (23.89%) and 75.00% (29.72%), respectively. The overall incidence of adverse events was relatively low, with only 16 patients (6.05%) reporting adverse events. Common adverse reactions such as conjunctivitis (2 cases, 0.71%) and facial erythema (1 case, 0.36%) were mild and well-tolerated. Phenotype switching occurred in 10 cases (3.56%) . Conclusion:Dupilumab was an effective and safe treatment for elderly AD, but phenotype switching may occur.
8.Analysis of clinical phenotypes and cenetic mutations in hereditary coagulation factor Ⅶ deficiency:A study of 66 cases
Longying YE ; Lihong YANG ; Yanhui JIN ; Fengjiao WANG ; Mingshan WANG
Chinese Journal of Clinical Laboratory Science 2025;43(11):836-841
Objective To investigate the mutation spectrum of F7 gene and its clinical implications in patients with coagulation factorⅦ(FⅦ)deficiency in the southeastern Chinese population,and to analyze the correlations among genotype,FⅦ activity(FⅦ:C),and bleeding risk.Methods A retrospective analysis was conducted on 66 probands diagnosed with FⅦ deficiency between 2010 and 2024 at The First Affiliated Hospital of Wenzhou Medical University.The clinical data,bleeding scores according to ISTH(Internation-al Society on Thrombosis and Haemostasis),the results of coagulation function tests,and F7 gene sequencing data were collected and analyzed.Results Among the 66 probands,59 cases exhibited severe FⅦ deficiency,of whom 37 presented bleeding symptoms,pri-marily gingival bleeding,epistaxis,and menorrhagia.The most frequent mutation:sp.His408Gln,p.Cys10Profs * 16,and p.Cys389Gly,were clustered in exon 8.Prothrombin time(PT)showed a significant positive correlation with ISTH bleeding scores(P<0.05),while FⅦ:C demonstrated weak predictive power for bleeding risk.Conclusion Exon 8 and the S1 peptide region of the F7 gene were identified as mutation hotspots,and PT was highlighted as an effective tool for evaluating bleeding risk.Although FⅦ:C levels exhibited only a limited correlation with bleeding risk,genetic mutation analysis provided crucial insights for the molecular diag-nosis and clinical management of FⅦ deficiency.
9.Evaluation of hospital infection risk assessment and prevention-control indicator system in stomatology outpatient department of general hospitals
Huijie ZHAO ; Lihong WANG ; Jiuping WANG ; Xu SUN ; Xia ZHAO ; Wenhui MA ; Yang YANG
Chinese Journal of Nosocomiology 2025;35(11):1729-1734
OBJECTIVE To construct a prevention and control index system suitable for stomatology outpatient de-partment of general hospital,so as to provide a theoretical basis for risk assessment of stomatology outpatient de-partment,and to provide an evidence-based basis for precise prevention and control.METHODS Based on the methods of literature research,literature quality evaluation and brainstorming,a draft index of the prevention and control of the general hospital's oral outpatient department was constructed,and the index system for the preven-tion and control in the stomatology outpatient department of a general hospital was finally established through re-search group discussion,content analysis and expert consultation.The three-level indicators in the index system were incorporated into the risk points of risk assessment,the failure mode and effects analysis were applied to con-duct the risk assessment,and the intervention measures and rectification cycles were formulated and implemented in clinical practice for the risk points with risk priority number(RPN)greater than 125.Based on the established index system and risk points with RPN>125,the hospital infection prevention and control checklist for stoma-tology outpatient was developed and regularly checked in the clinic.After the rectification was completed,the risk points were evaluated again,and the RPN values were compared before and after the risk control.RESULTS The recovery rate of expert consultation questionnaire was 100.00%,and the average expert authority coefficient was 0.84.The consistency ratio(CR)for the first-level indicators was 0.0499,and the consistency ratio(CR)of the second-level indicators was 0.0000-0.0790,which was less than 0.1,and the consistency was acceptable.Final-ly,a hospital infection prevention and control index system was established,comprising 5 first-level indicators,7 second-level indicators and 23 third-level indicators.The improved key control risk points were evaluated again,and the RPN values before and after comparing the risk control were reduced and<125,indicating that the im-provement measures were effective.CONCLUSION The evaluation system of prevention and control for the stoma-tology outpatient department of a general hospital established in this study is reliable,scientific and practical,and the improvement measures of risk assessment before and after the control of risk points are effective,which pro-vides evidence-based basis for risk assessment and precise prevention and control in the stomatology outpatient de-partment of general hospitals.
10.Correlation between type 2 diabetes and hepatitis B virus infection
Wu LIU ; Tianshuo ZHAO ; Liguo YANG ; Genxia GAO ; Wenli MIAO ; Tongxia ZENG ; Yonglan CHEN ; Lina ZHANG ; Xiaoyan CHE ; Lihong WANG ; Junhan ZHANG ; Bingfeng HAN ; Fuqiang CUI
Chinese Journal of Epidemiology 2025;46(5):833-839
Objective:To analyze the latent prevalence of hepatitis B and type 2 diabetes and their correlation through an observational study.Methods:This study used a case-control design. The cases with diabetes were recruited through the diabetes management system and village doctors, while the controls without diabetes were screened from volunteers recruited by village health clinics. Capillary blood samples were collected from the study participants for the measurement of real-time blood glucose level, and venous blood samples were taken from them for the detections of HBV serological markers. Firth logistic regression model was used to fit the relationship between HBsAg positive status and diabetes status.Results:The study included 1 218 diabetes patients, 62 patients with impaired fasting glucose and 491 cases without diabetes. In the cases without diagnosis of diabetes, 11.15% had impaired fasting blood glucose and 4.43% had diabetes. Among those who reported no or unknown diagnosis of hepatitis B, 1.73% were positive for HBsAg, while 18.80% were positive for both HBV core antibody and surface antibody, indicating latent infection of hepatitis B virus. In the non-diabetes group, 0.81% reported hepatitis B history, and in the diabetes group, 2.76% reported hepatitis B history. After adjustment, the HBsAg positive rate was higher in the diabetes group ( OR=2.90, 95% CI: 1.21-6.91). Conclusions:Both diabetes and hepatitis B exhibited a high degree of latent prevalence. The HBsAg positive rate was significantly higher in those with diabetes than in those without diabetes, indicating a potential correlation. These findings highlighted the importance of strengthened screening and management of comorbidities.

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